Mild Cognitive ImpairmentNCT06207903
Navigating the Clinical Research Process for Mild Cognitive Impairment
An observational study of Mild Cognitive Impairment, run by Power Life Sciences Inc. at 1 site in United States.
Trial summary
Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Mild cognitive impairment patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- Confirmed diagnosis of mild cognitive impairment
- Participant must be 18 years of age or older
- Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
Who cannot join
- Pregnant or lactating woman
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Power Life Sciences
San Francisco, California, 94107
Michael B Gill, 415-900-4227, https://www.withpower.com/contact-us@withpower.com
About this study
Official title: Investigating Participation Behavior: An Observational Study in Mild Cognitive Impairment Clinical Trials
Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This trial will admit a wide range of data on the clinical trial experience of mild cognitive impairment patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future mild cognitive impairment patients.
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who decide to enroll in a mild cognitive impairment clinical research.
Measured: 3 months
Number of mild cognitive impairment study participants who remain in clinical study until completion.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study startFeb 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207903
- Sponsor's protocol ID
- 58428170
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2024
- Last updated
- 17 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313.
PubMed 27042901Breton A, Casey D, Arnaoutoglou NA. Cognitive tests for the detection of mild cognitive impairment (MCI), the prodromal stage of dementia: Meta-analysis of diagnostic accuracy studies. Int J Geriatr Psychiatry. 2019 Feb;34(2):233-242. doi: 10.1002/gps.5016. Epub 2018 Nov 27.
PubMed 30370616Chou YH, Sundman M, Ton That V, Green J, Trapani C. Cortical excitability and plasticity in Alzheimer's disease and mild cognitive impairment: A systematic review and meta-analysis of transcranial magnetic stimulation studies. Ageing Res Rev. 2022 Aug;79:101660. doi: 10.1016/j.arr.2022.101660. Epub 2022 Jun 6.
PubMed 35680080
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Participation Behavior: An Observational Study in Mild Cognitive Impairment Clinical Trials
- ClinicalTrials.gov ID
- NCT06207903
- Acronym / sponsor ID
- 58428170
- Conditions
- Mild Cognitive Impairment
- Keywords
- mild cognitive impairment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participation in medical research usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.
This trial will admit a wide range of data on the clinical trial experience of mild cognitive impairment patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.
It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future mild cognitive impairment patients.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Mild cognitive impairment patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- Confirmed diagnosis of mild cognitive impairment
- Participant must be 18 years of age or older
- Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.
Key exclusion criteria (3 listed)
- Pregnant or lactating woman
- Participant is actively receiving study therapy in another
- Inability to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients who decide to enroll in a mild cognitive impairment clinical research.
Time frame: 3 months
Number of mild cognitive impairment study participants who remain in clinical study until completion.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Background: PubMed 27042901Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313.
- Background: PubMed 30370616Breton A, Casey D, Arnaoutoglou NA. Cognitive tests for the detection of mild cognitive impairment (MCI), the prodromal stage of dementia: Meta-analysis of diagnostic accuracy studies. Int J Geriatr Psychiatry. 2019 Feb;34(2):233-242. doi: 10.1002/gps.5016. Epub 2018 Nov 27.
- Background: PubMed 35680080Chou YH, Sundman M, Ton That V, Green J, Trapani C. Cortical excitability and plasticity in Alzheimer's disease and mild cognitive impairment: A systematic review and meta-analysis of transcranial magnetic stimulation studies. Ageing Res Rev. 2022 Aug;79:101660. doi: 10.1016/j.arr.2022.101660. Epub 2022 Jun 6.
- Individual participant dataSharing planned: Undecided
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
A First-In-Human Study of LY3954068 in Participants With Early Symptomatic Alzheimer's Disease
Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Recruiting
Non-invasive Brain Stimulation for the Treatment of Mild Cognitive Impairment in Parkinson's Disease
Parkinson Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael B Gill study director
Power Life Sciences Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Power Life Sciences Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who decide to enroll in a mild cognitive impairment clinical research. (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207903, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.